Associate Director, Quality Assurance

Role Overview

We are hiring an Associate Director, Quality Assurance to manage Quality Systems personnel and activities for FUJIFILM Biosciences at our Pennsylvania site. The role involves managing incoming QA inspection of raw materials, raw material source and qualification program, internal and supplier audit programs, customer audit management, document control, quality control, batch releases, change notification, deviation, complaint, investigation, continuous improvement, audits, validations, system reviews and various customer and internal support as required.

What You Will Do

Provides leadership and guidance to the Quality Assurance team, develops Quality Systems, establishes partnerships with business stakeholders, and acts as a quality resource with expertise in quality regulations.

Why It Might Be a Fit

The successful candidate will have 10+ years of direct Quality Systems experience in the pharmaceutical, medical device and/or Bio sciences industry, 5+ years of Management experience, and a B.S. in Microbiology/Chemistry/Biology/Engineering or equivalent education.

Requirements

• B.S. in Microbiology/Chemistry/Biology/Engineering or equivalent education
• 10 or more years of direct Quality Systems experience in the pharmaceutical, medical device and/or Bio sciences industry
• 5+ years of Management experience
• Detailed knowledge of ISO 9001/13485, ICH/FDA guidelines
• Ability to speak, read, and write in English
• Good oral and written communication skills and good presentation skills

Benefits

• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off